Events

Rappel de Device Recall Teco Diagnostics Uritek TC101 Urine Analyzer

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Teco Diagnostics.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57157
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0582-2011
  • Date de mise en oeuvre de l'événement
    2010-10-01
  • Date de publication de l'événement
    2010-12-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-03
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95490
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Automated urinalysis system - Product Code KQO
  • Cause
    This recall has been initiated due to the clia-101 urine analyzer not having 510(k) clearance by the fda for use in measuring urinary glucose or occult blood with the clia waived, inc. clia-10 test strips. teco diagnostics has been notified by the fda that the clia-101 requires 510(k) clearance and is not clia waived for use with the clia-10 test strips. without fda approval or clearance, teco di.
  • Action
    Teco Diagnostics initiated an "Urgent: Medical Device Recall" letter dated October 14, 2010, with an attached "Recall Return Response Form" to the affected consignees via US Postal on October 15, 2010. The recall notice informed the consignees of the reason for recall, the products affected and the actions required. Consignees were instructed to complete and return the enclosed Recall Return Response Form as soon as possible via mail, fax, or email. Upon receipt of the Recall Return Response Form, Teco Diagnostics would work with the consignees/distributors to process any refunds or reimbursements for the returned product and return shipping. If consignees/distributor had questions, they were to call Teco's Technical Support Department at (800) 222-9880 or (714) 463-1111.

Device

Device Recall Teco Diagnostics Uritek TC101 Urine Analyzer
  • Modèle / numéro de série
    All units sold (2005 - 2010)
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, AND WV and the country of Canada.
  • Description du dispositif
    NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer || The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.
  • Manufacturer
    Teco Diagnostics

Manufacturer

Teco Diagnostics
  • Adresse du fabricant
    Teco Diagnostics, 1268 N Lakeview Ave, Anaheim CA 92807-1831
  • Source
    USFDA